Directions

The dose should be prescribed using a combination of whole tablet strengths (62.5 mg, 125 mg, 250 mg, 375 mg). Do not remove from foil strip until ready to use. Even if the tablet is broken, the entire tablet should be consumed.

Dogs

The recommended dosage of Clavamox Chewable Tablet is 6.25mg/lb of body weight twice a day.

Skin and soft tissue infections such as abscesses, cellulitis, wounds, superficial/juvenile pyoderma, and periodontal infections should be treated for 5-7days or for 48hours after all symptoms have subsided. If no response is seen after 5days of treatment, therapy should be discontinued and the case reevaluated. Deep pyoderma may require treatment for 21days; the maximum duration of treatment should not exceed 30days.

Cats

The recommended dosage of Clavamox Chewable Tablet is 62.5mg twice a day.

Skin and soft tissue infections such as abscesses and cellulitis/dermatitis should be treated for 5-7days or for 48hours after all symptoms have subsided, not to exceed 30days. If no response is seen after 3days of treatment, therapy should be discontinued and the case reevaluated.

Urinary tract infections may require treatment for 10-14days or longer. The maximum duration of treatment should not exceed 30days.

Caution

Federal (USA) law restricts this drug to use by or on the order of a licensed veterinarian.

Contraindications

The use of this drug is contraindicated in animals with a history of allergic reaction to any of the penicillins or cephalosporins.

Warnings

Store Clavamox Chewable out of reach of dogs, cats, and other pets in a secured location in order to prevent accidental ingestion or overdose.

Human Warnings

Not for human use. Keep this and all drugs out of reach of children. Antimicrobial drugs, including penicillins and cephalosporins, can cause allergic reactions in sensitized individuals. To minimize the possibility of allergic reactions, those handling such antimicrobials, including amoxicillin and clavulanate potassium, are advised to avoid direct contact of the product with the skin and mucous membranes.

Precautions

Prescribing antibacterial drugs in the absence of a proven or strongly suspected bacterial infection is unlikely to provide benefit to treated animals and may increase the risk of the development of drug-resistant animal pathogens. Safety of use in pregnant or breeding animals has not been determined.

Adverse Reactions

Clavamox Chewable contains a semisynthetic penicillin (amoxicillin) and has the potential for producing allergic reactions. If an allergic reaction occurs, administer epinephrine and/or steroids.

To report suspected adverse events, for technical assistance or to obtain a copy of the SDS, contact Zoetis Inc. at 1-888-963-8471 or www.zoetis.com.

For additional information about adverse drug experience reporting for animal drugs, contact FDA at 1-888-FDA-VETS or online at http://www.fda.gov/AnimalVeterinary/SafetyHealth.

Actions

The 2 components are rapidly absorbed resulting in amoxicillin and clavulanic acid concentrations in serum, urine, and tissues similar to those produced when each is administered alone.

Amoxicillin and clavulanic acid diffuse readily into most body tissues and fluids with the exception of brain and spinal fluid, which amoxicillin penetrates adequately when meninges are inflamed. Most of the amoxicillin is excreted unchanged in the urine. Clavulanic acid’s penetration into spinal fluid is unknown at this time. Approximately 15% of the administered dose of clavulanic acid is excreted in the urine within the first 6 hours.

Clavamox Chewable combines the distinctive properties of a broad-spectrum antibiotic and a ?-lactamase inhibitor to effectively extend the antibacterial spectrum of amoxicillin to include ?-lactamase-producing as well as non-?-lactamase-producing aerobic and anaerobic organisms.

Microbiology

Amoxicillin is bactericidal in action and acts through the inhibition of biosynthesis of cell wall mucopeptide of susceptible organisms. The action of clavulanic acid extends the antimicrobial spectrum of amoxicillin to include organisms resistant to amoxicillin and other ?-lactam antibiotics. Amoxicillin/clavulanate has been shown to have a wide range of activity which includes ?-lactamase-producing strains of both gram-positive and gram-negative aerobes, facultative anaerobes, and obligate anaerobes. Many strains of the following organisms, including ß-lactamase-producing strains, isolated from veterinary sources, were found to be susceptible to amoxicillin/clavulanate in vitro but the clinical significance of this activity has not been demonstrated for some of these organisms in animals.

Aerobic bacteria, including Staphylococcus aureus*, ß-lactamase-producing Staphylococcus aureus* (penicillin resistant), Staphylococcus species*, Staphylococcus epidermidis, Staphylococcus intermedius, Streptococcus faecalis, Streptococcusspecies*, Corynebacterium pyogenes, Corynebacterium species, Erysipelothrix rhusiopathiae, Bordetella bronchiseptica, Escherichia coli*, Proteus mirabilis, Proteusspecies, Enterobacter species, Klebsiella pneumoniae, Salmonella dublin, Salmonella typhimurium, Pasteurella multocida, Pasteurella hemolytica, Pasteurella species*.

* The susceptibility of these organisms has also been demonstrated in in vivo studies.Studies have demonstrated that both aerobic and anaerobic flora are isolated from gingival cultures of dogs with clinical evidence of periodontal disease. Both gram-positive and gram-negative aerobic and anaerobic subgingival isolates indicate sensitivity to amoxicillin/clavulanic acid during antimicrobial susceptibility testing.

Palatability

The palatability of Clavamox Chewable Tablets was evaluated in a multi-location field trial. One hundred twelve (112) client-owned dogs were dosed with Clavamox Chewable Tablets at 6.25 mg/lb (12.5 mg/kg) twice daily for 7 days and evaluated for palatability of the product. Dogs freely consumed 83% of their doses within 5 minutes of offering from an empty bowl or owner’s hand. Of the 17% of doses unconsumed after 5 minutes, 16% were administered with a treat/food or forced intake and 1% of doses were refused.

Storage

Store in a dry, cool place at temperatures not above 25°C (77°F). Do not remove from foil strip until ready to use.